Effective patent life in pharmaceuticals

Abstract

Effective patent life is lost in pharmaceuticals because of the lengthy time periods required for clinical trials and regulatory approval. A 1984 US law restores some of this lost patent time, while also facilitating generic competition when patents expire. This paper examines this law and the effects of other policy developments on market exclusivity times in pharmaceuticals. It also performs simulation analyses on how proposed legislative reforms would impact on future new drug introductions.